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Webinar On Good Clinical Practices (GCP)

This webinar is intended to help you adequately implement Good Clinical Practices including documentation requirements during clinical trials for both drugs and medical devices.

Description :This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements during clinical trials for both drugs and medical devices.To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.GCP requirements including documentation requirements (a set of SOPs) with key elements to be contained in the SOP will be discussed.In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety.Areas Covered in the Session :Laws and RegulationsDefinitionsClinical Trials and RequirementsRegulatory Requirements for INDs and IDEs.Duties and Responsibilities for Clinical Investigators (CI), Institutional Review Boards (IRBs), Sponsors and Monitors, and Contract Research Organizations (CROs)ICH-GCP GuidelinesISO 14155List of SOPs and Adequate DocumentationKey Elements in the SOPsCommon GCP Deficiencies in EU and USEnforcement ActionsLessons LearnedWho Will Benefit:Clinical AffairsRegulatory AffairsQuality AssuranceResearch & DevelopmentConsultantsContractors/SubcontractorsSenior ManagementAnyone Interested in the TopicPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 

When

22 Jun 2015 @ 01:00 pm

22 Jun 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Organised by

FutureCorp Consulting (deactivated)

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